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The Phoenix Company of Chicago is pleased to announce its Shanghai, China facility's quality management system is certified compliant with the requirements of ISO 13485:2003 (EN ISO 13485:2012) quality standard for manufacturers of medical devices.

Shanghai Phoenix has also re-certified for the ISO 9001:2008 quality management standard. Both certifications signify Phoenix's commitment to providing products and services with attention to quality, safety, consistency, and customer satisfaction.

About ISO 13485:2003

ISO 13485:2003 specifies requirements for an organization's quality management systems to demonstrate a commitment to customer requirements, safety, and quality of medical devices and adhere to regulatory requirements for the manufacturing, assembly, and distribution of medical devices.